Topic:

Regulatory

Latest Headlines

Latest Headlines

Sanofi nears European Gaucher market shakeup with EMA rec

In August, Sanofi's Genzyme won the FDA's blessing to take brand-new orphan drug Cerdelga into the U.S. Gaucher disease market, where the company hoped the pill could show up older, intravenous treatments. And now, it could be on its way to the same opportunity in the EU.

Beware sketchy biotechs with big plans for Ebola, SEC says

The SEC has suspended the trading of a few microcap companies touting unverified Ebola treatments and tests, warning investors of penny stock peddlers looking to cash in on the West African outbreak that has killed thousands.

Novartis' Enbrel beater bounds toward psoriasis approval ahead of the crowd

Novartis is well on its way to leading a new class of anti-inflammatory treatments, convincing European regulators to recommend approving its injected therapy for psoriasis and putting the company in line for transatlantic launches next year.

Boehringer one step closer to challenging Roche in Europe with EMA IPF nod

Boehringer Ingelheim's Ofev and Roche's Esbriet became the first two U.S.-approved treatments for idiopathic pulmonary fibrosis when the FDA green-lighted them on the same day last month. And while Roche has the lead with Esbriet in Europe, Boehringer is now one step closer to leveling the playing field on the continent.

FDA delays UDI labeling requirements by two years for some orthopedic devices

The FDA originally proposed requiring implantable medical devices to bear a unique device identification code on their surface. But industry protested that part of the proposed rule, so the agency ultimately opted to rely on packaging as the surface for UDIs. However, some orthopedics are removed from their packaging well before surgery or implantation, forcing the FDA to make a change on the fly.

AbbVie gets an EU green light for its next-gen hep C treatment

AbbVie is one step closer to challenging Gilead Sciences' dominance in the hepatitis C market, securing a likely European approval for its rival combo treatment as it awaits a U.S. nod.

FDA approves Purdue's abuse-resistant Hysingla, a hydrocodone pill aimed at knocking off Zohydro

The FDA has faced a firestorm of criticism since approving Zogenix's superstrength painkiller Zohydro last year, drawing outcry from lawmakers and industry groups concerned with the drug's all-hydrocodone formula. Now, discontent could swell even further as the agency signs off on Purdue Pharma's opioid treatment Hysingla for chronic pain.

Purdue wins a pain pill approval with Zohydro in its crosshairs

The FDA approved Purdue Pharma's latest pain drug, a hydrocodone formulation designed to prevent abuse, potentially spelling trouble for Zogenix and its controversial Zohydro.

Court shoots down Ranbaxy's bid to block rival Nexium and Valcyte generics

Ranbaxy Laboratories suffered a stinging setback in its battle to keep copies of AstraZeneca's blood pressure med Nexium and Roche's antiviral Valcyte off the market, as a U.S. court denied its request for a temporary restraining order against companies producing generic versions of the drugs.

Ranbaxy can't stop the FDA from yanking drug approvals over plant problems

A U.S. federal judge has turned down Ranbaxy Laboratories' request for a temporary restraining order against the FDA after the agency revoked the Indian drugmaker's approvals to make generics of AstraZeneca's blockbuster Nexium and Roche's antiviral Valcyte because of its manufacturing shortcomings.